Decision Date2013-03-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
MICROLINE FLEXIBLE LIGATING SHEARS is the device name listed in this FDA 510(k) record. The listed applicant is Microline Surgical, Inc.. It received FDA 510(k) clearance on 2013-03-27 under 510(k) number K124029. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MICROLINE FLEXIBLE LIGATING SHEARS?
MICROLINE FLEXIBLE LIGATING SHEARS is a medical device that received FDA 510(k) clearance on 2013-03-27. The listed applicant is Microline Surgical, Inc.. The 510(k) number is K124029.
When did MICROLINE FLEXIBLE LIGATING SHEARS receive FDA 510(k) clearance?
MICROLINE FLEXIBLE LIGATING SHEARS received FDA 510(k) clearance on 2013-03-27, under 510(k) number K124029.
Who is the listed applicant for MICROLINE FLEXIBLE LIGATING SHEARS?
The FDA 510(k) record lists Microline Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MICROLINE FLEXIBLE LIGATING SHEARS?
The FDA product code for MICROLINE FLEXIBLE LIGATING SHEARS is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.